A Randomized Trial of Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting.

BACKGROUND & AIMS: Mailed outreach for colorectal cancer (CRC) screening increases uptake but it is unclear how to offer the choice of testing. We evaluated if the active choice between colonoscopy and fecal immunochemical test (FIT), or FIT alone, increased response compared with colonoscopy alone. METHODS: This pragmatic, randomized, controlled trial at a community health center included patients between ages 50 and 74 who were not up to date with CRC screening. Patients were randomized 1:1:1 to the following: (1) colonoscopy only, (2) active choice of colonoscopy or FIT, or (3) FIT only. Patients received an outreach letter with instructions for testing (colonoscopy referral and/or an enclosed FIT kit), a reminder letter at 2 months, and another reminder at 3 to 5 months via text message or automated voice recording. The primary outcome was CRC screening completion within 6 months. RESULTS: Among 738 patients in the final analysis, the mean age was 58.7 years (SD, 6.2 y); 48.6% were insured by Medicaid and 24.3% were insured by Medicare; and 71.7% were White, 16.9% were Black, and 7.3% were Hispanic/Latino. At 6 months, 5.6% (95% CI, 2.8-8.5) completed screening in the colonoscopy-only arm, 12.8% (95% CI, 8.6-17.0) in the active-choice arm, and 11.3% (95% CI, 7.4-15.3) in the FIT-only arm. Compared with colonoscopy only, there was a significant increase in screening in active choice (absolute difference, 7.1%; 95% CI, 2.0-12.2; P = .006) and FIT only (absolute difference, 5.7%; 95% CI, 0.8-10.6; P = .02). CONCLUSIONS: Both choice of testing and FIT alone increased response and may align with patient preferences. TRIAL REGISTRATION: clinicaltrials.gov NCT04711473.

Practical considerations for sandwich variance estimation in two-stage regression settings.

We present a practical approach for computing the sandwich variance estimator in two-stage regression model settings. As a motivating example for two-stage regression, we consider regression calibration, a popular approach for addressing covariate measurement error. The sandwich variance approach has been rarely applied in regression calibration, despite it requiring less computation time than popular resampling approaches for variance estimation, specifically the bootstrap. This is likely due to requiring specialized statistical coding. We first outline the steps needed to compute the sandwich variance estimator. We then develop a convenient method of computation in R for sandwich variance estimation, which leverages standard regression model outputs and existing R functions and can be applied in the case of a simple random sample or complex survey design. We use a simulation study to compare the sandwich to a resampling variance approach for both settings. Finally, we further compare these two variance estimation approaches for data examples from the Women's Health Initiative (WHI) and Hispanic Community Health Study/Study of Latinos (HCHS/SOL). The sandwich variance estimator typically had good numerical performance, but simple Wald bootstrap confidence intervals were unstable or over-covered in certain settings, particularly when there was high correlation between covariates or large measurement error.

Persistent Disparities in Smoking Rates Among PLWH Compared to the General Population in Philadelphia, 2009-2014.

Despite reductions in smoking rates in the general population, little is known about recent smoking trends among people living with HIV (PLWH). We compared the risk for smoking and temporal trends in smoking among PLWH and the general population in the Philadelphia metropolitan area between 2009 and 2014. We used weighted logistic regression to assess the relation between HIV and smoking, and examined temporal smoking trends. The adjusted odds ratio (OR) for smoking comparing PLWH to the general population was 1.80 (95% CI 1.55-2.09) after adjusting for socio-economic, demographic, and mental health diagnosis variables. Smoking prevalence decreased in both the PLWH and general populations during the study period, and we did not observe a significant difference in rates of decline between groups (P = 0.54). Despite overall progress in smoking cessation, a disparity persisted in smoking rates between PLWH and the general population, with and without adjustment for socio-economic, demographic, and mental health variables. Further research is needed to understand the mechanisms linking HIV and tobacco use in order to inform public health efforts to reduce smoking among PLWH.

The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight-loss maintenance.

Background Obesity continues to be a serious public health challenge. Rates are increasing worldwide, with nearly 70% of the US adults overweight or obese, leading to increased clinical and economic burden. While successful approaches for achieving weight loss have been identified, techniques for long-term maintenance of initial weight loss have largely been unsuccessful. Financial incentive interventions have been shown in several settings to be successful in motivating participants to adopt healthy behaviors. Purpose Keep It Off is a three-arm randomized controlled trial that compares the efficacy of a lottery-based incentive, traditional direct payment incentive, and control of daily feedback without any incentive for weight-loss maintenance. This design allows comparison of a traditional direct payment incentive with one based on behavioral economic principles that consider the underlying psychology of decision-making. Methods Participants were randomized in a 2:1 ratio for each active arm relative to control, with a targeted 188 participants in total. Eligible participants were those aged 30-80 who lost at least 11 lb (5 kg) during the first 4 months of participation in Weight Watchers, a national weight-loss program, with whom we partnered. The interventions lasted 6 months (Phase I); participants were followed for an additional 6 months without intervention (Phase II). The primary outcome is weight change from baseline to the end of Phase I, with the change at the end of Phase II a key secondary endpoint. Keep It Off is a pragmatic trial that recruited, consented, enrolled, and followed patients electronically. Participants were provided a wireless weight scale that electronically transmitted daily self-monitored weights. Weights were verified every 3 months at a Weight Watchers center local to the participant and electronically transmitted. Results Using the study web-based platform, we integrated recruitment, enrollment, and follow-up procedures into a digital platform that required little staff effort to implement and manage. We randomized 191 participants in less than 1 year. We describe the design of Keep It Off and implementation of enrollment. Lessons Learned We demonstrated that our pragmatic design was successful in rapid accrual of participants in a trial of interventions to maintain weight loss. Limitations Despite the nationwide reach of Weight Watchers, the generalizability of study findings may be limited by the characteristics of its members. The interventions under study are appropriate for settings where an entity, such as an employer or health insurance company, could offer them as a benefit. Conclusions Keep It Off was implemented and conducted with minimal staff effort. This study has the potential to identify a practical and effective weight-loss maintenance strategy.

Determinants of hospital outcomes for patients with COVID-19 in the University of Pennsylvania Health System.

There is growing evidence that racial and ethnic minorities bear a disproportionate burden from COVID-19. Temporal changes in the pandemic epidemiology and diversity in the clinical course require careful study to identify determinants of poor outcomes. We analyzed 6255 hospitalized individuals with PCR-confirmed SARS-CoV-2 infection from one of 5 hospitals in the University of Pennsylvania Health System between March 2020 and March 2021, using electronic health records to assess risk factors and outcomes through 8 weeks post-admission. Discharge, readmission and mortality outcomes were analyzed in a multi-state model with multivariable Cox models for each transition. Mortality varied markedly over time, with cumulative incidence (95% CI) 30 days post-admission of 19.1% (16.9, 21.3) in March-April 2020, 5.7% (4.2, 7.5) in July-October 2020 and 10.5% (9.1,12.0) in January-March 2021; 26% of deaths occurred after discharge. Average age (SD) at admission varied from 62.7 (17.6) to 54.8 (19.9) to 60.5 (18.1); mechanical ventilation use declined from 21.3% to 9-11%. Compared to Caucasian, Black race was associated with more severe disease at admission, higher rates of co-morbidities and residing in a low-income zip code. Between-race risk differences in mortality risk diminished in multivariable models; while admitting hospital, increasing age, admission early in the pandemic, and severe disease and low blood pressure at admission were associated with increased mortality hazard. Hispanic ethnicity was associated with fewer baseline co-morbidities and lower mortality hazard (0.57, 95% CI: 0.37, .087). Multi-state modeling allows for a unified framework to analyze multiple outcomes throughout the disease course. Morbidity and mortality for hospitalized COVID-19 patients varied over time but post-discharge mortality remained non-trivial. Black race was associated with more risk factors for morbidity and with treatment at hospitals with lower mortality. Multivariable models suggest there are not between-race differences in outcomes. Future work is needed to better understand the identified between-hospital differences in mortality.

Effect of Financial Incentives and Environmental Strategies on Weight Loss in the Healthy Weigh Study: A Randomized Clinical Trial.

Importance: Modest weight loss can lead to meaningful risk reduction in adults with obesity. Although both behavioral economic incentives and environmental change strategies have shown promise for initial weight loss, to date they have not been combined, or compared, in a randomized clinical trial. Objective: To test the relative effectiveness of financial incentives and environmental strategies, alone and in combination, on initial weight loss and maintenance of weight loss in adults with obesity. Design, Setting, and Participants: This randomized clinical trial was conducted from 2015 to 2019 at 3 large employers in Philadelphia, Pennsylvania. A 2-by-2 factorial design was used to compare the effects of lottery-based financial incentives, environmental strategies, and their combination vs usual care on weight loss and maintenance. Interventions were delivered via website, text messages, and social media. Participants included adult employees with a body mass index (BMI; weight in kilograms divided by height in meters squared) of 30 to 55 and at least 1 other cardiovascular risk factor. Data analysis was performed from June to July 2021. Interventions: Interventions included lottery-based financial incentives based on meeting weight loss goals, environmental change strategies tailored for individuals and delivered by text messages and social media, and combined incentives and environmental strategies. Main Outcome and Measures: The primary outcome was weight change from baseline to 18 months, measured in person. Results: A total of 344 participants were enrolled, with 86 participants each randomized to the financial incentives group, environmental strategies group, combined financial incentives and environmental strategies group, and usual care (control) group. Participants had a mean (SD) age of 45.6 (10.5) years and a mean (SD) BMI of 36.5 (7.1); 247 participants (71.8%) were women, 172 (50.0%) were Black, and 138 (40.1%) were White. At the primary end point of 18 months, participants in the incentives group lost a mean of 5.4 lb (95% CI, -11.3 to 0.5 lb [mean, 2.45 kg; 95% CI, -5.09 to 0.23 kg]), those in the environmental strategies group lost a mean of a 2.2 lb (95% CI, -7.7 to 3.3 lb [mean, 1.00 kg; 95% CI, -3.47 to 1.49 kg]), and the combination group lost a mean of 2.4 lb (95% CI, -8.2 to 3.3 lb [mean, 1.09 kg; 95% CI, -3.69 to 1.49 kg]) more than participants in the usual care group. Financial incentives, environmental change strategies, and their combination were not significantly more effective than usual care. At 24 months, after 6 months without an intervention, the difference in the change from baseline was similar to the 18-month results, with no significant differences among groups. Conclusions and Relevance: In this randomized clinical trial, across all study groups, participants lost a modest amount of weight but those who received financial incentives, environmental change, or the combined intervention did not lose significantly more weight than those in the usual care group. Employees with obesity may benefit from more intensive individualized weight loss strategies. Trial Registration: ClinicalTrials.gov Identifier: NCT02878343.

Financial incentive strategies for maintenance of weight loss: results from an internet-based randomized controlled trial.

BACKGROUND/OBJECTIVE: Financial incentives can improve initial weight loss; we examined whether financial incentives can improve weight loss maintenance. SUBJECTS/METHODS: Participants aged 30-80 years who lost at least 5 kg during the first 4-6 months in a nationally available commercial weight loss program were recruited via the internet into a three-arm randomized trial of two types of financial incentives versus active control during months 1-6 (Phase I) followed by passive monitoring during months 7-12 (Phase II). Interventions were daily self-weighing and text messaging feedback alone (control) or combined with a lottery-based incentive or a direct incentive. The primary outcome was weight change 6 months after initial weight loss. Secondary outcomes included weight change 12 months after initial weight loss (6 months after cessation of maintenance intervention), and self-reported physical activity and eating behaviors. RESULTS: Of 191 participants randomized, the mean age was 49.0 (SD = 10.5) years and weight loss prior to randomization was 11.4 (4.7) kg; 92% were women and 89% were White. Mean weight changes during the next 6 months (Phase I) were: lottery -3.0 (5.8) kg; direct -2.8 (5.8) kg; and control -1.4 (5.8) kg (all pairwise comparisons p > 0.1). Weight changes through the end of 12 months post-weight loss (Phase II) were: lottery -1.8 (10.5) kg; direct -0.7 (10.7) kg; and control -0.3 (9.4) kg (all pairwise comparisons p > 0.1). The percentages of participants who maintained their weight loss (defined as gaining ≤1.36 kg) were: lottery 79%, direct 76%, and control 67% at 6 months and lottery 66%, direct 62%, and control 59% at 12 months (all pairwise comparisons p > 0.1). At 6 and 12 months after initial weight loss, changes in self-reported physical activity or eating behaviors did not differ across arms. CONCLUSIONS: Compared with the active control of daily texting based on daily home weighing, lottery-based and direct monetary incentives provided no additional benefit for weight loss maintenance.